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CHRONO-PAR® Arachidonic Acid

by Chrono-log Corp

Ref 390 Arachidonic Acid

CHRONO-PAR® Arachidonic Acid (390 Arachidonic Acid) is a Class A device made by Chrono-Log Corp, registered in EUDAMED on 18 May 2022 (Basic UDI-DI 081147601Reagents3Z2), cleared under FDA 510(k) K850592 on 13 May 1985 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00811476010154), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K850592

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081147601Reagents3Z2 Basic UDI-DI 00811476010154UDI-DIDate18 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00811476010154 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK850592 Date13 May 1985DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081147601Reagents3Z2 registered 18 May 2022 Active
  • FDA 510(k) K850592 decided 13 May 1985 Active
  • FDA GUDID UDI-DI 00811476010154 listed 11 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K850592
  2. Listed FDA GUDID 00811476010154
  3. Registered EUDAMED 081147601Reagents3Z2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CHRONO-PAR® Arachidonic Acid EUDAMED
Chrono-Par GUDID
Generic name
Platelet aggregation study IVD, reagent
Device name
Reagents
Model / reference
390 Arachidonic Acid EUDAMED
390 GUDID
Primary DI / UDI-DI
00811476010154
Basic UDI-DI
081147601Reagents3Z2
510(k) Number
EMDN code
W01030199 Haematology reagents - other
GMDN term
Platelet aggregation study IVD, reagent
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
390 Arachidonic Acid
GUDID
390

Manufacturer details

EUDAMED SRN
US-MF-000018631
Authorised representative
BioTop Medical NL-AR-000012565

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

Other devices from Chrono-Log Corp

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)